Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00220987




Registration number
NCT00220987
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
29/01/2009

Titles & IDs
Public title
Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE - SUGAR STUDY)
Scientific title
A Multi-Center, Open Label Randomized Stratified Controlled Trial of the Effects of Blood Glucose Management on 90-Day All-Cause Mortality in a Heterogenous Population of Intensive Care Unit (ICU) Patients.
Secondary ID [1] 0 0
NHMRC GRANT - 293201
Secondary ID [2] 0 0
GI-IAT-NIC-G
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycemia 0 0
Critical Illness 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intensive Insulin Therapy
Other interventions - Conventional Insulin therapy

Experimental: Intensive Insulin therapy - Intensive Insulin therapy

Active comparator: Conventional Therapy - conventional insulin therapy


Other interventions: Intensive Insulin Therapy
Maintain blood glucose 4.5 - 6.o mmol/L

Other interventions: Conventional Insulin therapy
Maintain blood glucose 8-10mmol/L
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
all-cause mortality
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
The secondary outcomes, also determined over the same period of 90 days include:
Timepoint [1] 0 0
90 days
Secondary outcome [2] 0 0
All cause mortality
Timepoint [2] 0 0
Day 28
Secondary outcome [3] 0 0
Length of intensive care unit stay;
Timepoint [3] 0 0
90 days
Secondary outcome [4] 0 0
Length of hospital stay;
Timepoint [4] 0 0
90 Days
Secondary outcome [5] 0 0
The need for organ support (inotropes, renal replacement therapy and positive pressure ventilation);
Timepoint [5] 0 0
90 Days
Secondary outcome [6] 0 0
Incidence of blood stream infections;
Timepoint [6] 0 0
90 Days
Secondary outcome [7] 0 0
Incidence and severity of hypoglycaemia;
Timepoint [7] 0 0
90 Days
Secondary outcome [8] 0 0
extended glasgow outcome score
Timepoint [8] 0 0
2 years

Eligibility
Key inclusion criteria
* Patients are eligible for INCLUSION in the study if ALL the following criteria are met:

1. At time of the patient's admission to the ICU the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the calendar day following the day of admission.
2. Patient has an arterial line in situ or placement of an arterial line is imminent (within the next hour) as part of routine ICU management.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:

1. Age < 18 years.
2. Imminent death (cardiac standstill or brain death anticipated in less than 24 hours) and the treating clinicians are not committed to full supportive care. This should be confirmed by a documented treatment-limitation order that exceeds a "not-for-resuscitation" order.
3. Patients admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state.
4. Patient is expected to be eating before the end of the day following admission
5. Patients who have suffered hypoglycaemia without documented full neurological recovery.
6. Patient thought to be at abnormally high risk of suffering hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or recurrent hypoglycaemia or fulminant hepatic failure)
7. If a patient has previously been enrolled in the NICE-SUGAR Study (patients cannot be enrolled in the NICE-SUGAR Study more than once).
8. If the patient can not provide prior informed consent, there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent
9. The patient has been in the study ICU or another ICU for longer than 24 hours for this admission.

There is no upper age limit for inclusion into the study unless any of the specific exclusion criteria are present.

-

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
6104
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for International Health - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian and New Zealand Intensive Care Society Clinical Trials Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Critical Care Trials Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National Health and Medical Research Council, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Health Research Council, New Zealand
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of British Columbia
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary aim of the study is to compare the effects of the two blood glucose targets on 90 day all-cause mortality in Intensive Care patients who are predicted on admission to stay in the ICU for at least one full calendar day. The hypothesis is that there is little difference in the relative risk of death between patients assigned a glucose range of 4.5 - 6.0 mmol/L, and those assigned a glucose range of less than 10.0 mmol/L with insulin being infused if blood glucose exceeds 10.0 mmol/L, and adjusted when needed to maintain blood glucose of 8.0 - 10.0 mmol/L.
Trial website
https://clinicaltrials.gov/study/NCT00220987
Trial related presentations / publications
NICE-SUGAR Study Investigators; Finfer S, Liu B, Chittock DR, Norton R, Myburgh JA, McArthur C, Mitchell I, Foster D, Dhingra V, Henderson WR, Ronco JJ, Bellomo R, Cook D, McDonald E, Dodek P, Hebert PC, Heyland DK, Robinson BG. Hypoglycemia and risk of death in critically ill patients. N Engl J Med. 2012 Sep 20;367(12):1108-18. doi: 10.1056/NEJMoa1204942.
NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.
Public notes

Contacts
Principal investigator
Name 0 0
Simon Finfer, MBBS
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00220987